1. Field of the Invention
In accordance with the classification of art as established in and by the U.S. Patent Office, this invention is believed to pertain to special containers and also to the mixing of potent drugs as found in the general class of "Surgery." This drug isolation and mixing device utilizes a flexible bag in which the diluent is placed. About midway of the device is mounted a glass vial having a special configuration and a cover member. Removal of the cover while still within the bag enables the drug to be mixed with the diluent for subsequent injection into a patient.
2. Description of the Prior Art
A careful pre-Ex search was made in the files of the U.S. Patent Office and although drug mixing and packages for such drugs were noted, the concept of storing the potent drug in an impervious container with a removable cap as provided by applicant was not found. A drug isolation device was the subject of U.S. Pat. No. 1,585,911 to Heublein as issued May 25, 1926. This patent illustrated a glass ampule having two compartments and having in one compartment a liquid and in the other the drug (usually a powder). A lever portion is manipulated to break a stem portion and allow the fluid to enter the drug compartment where it is mixed. The ampule is broken to the extent that this mixed drug is removed usually by a syringe. The objection to this device is the potentiality of broken glass and the possibility of exposure to the practitioner.
Also of note is U.S. Pat. No. 3,163,163 to Wilburn, as issued Dec. 29, 1964. This patent shows a container with a reduced center portion in which is tightly secured a rubber stopper. This stopper is displaced into the lower container portion and permits the two portions to be intermixed. This invention requires a container having at least a partially deformable resilient top portion that utilizes the fluid in this upper portion to assist in the displacement of the stopper. It is to be noted that the stopper may be displaced by accidental pressure. Not mentioned is that fluids tend to pass through resilient stoppers when they provide the barrier wall as shown in FIG. 1 or 4 of U.S. Pat. No. 3,163,163.
A two-compartment container is provided in U.S. Pat. No. 4,315,570 to Silver et al., as issued Feb. 16, 1982. This patent also utilizes a plunger and a stopper moved by this plunger. The lower end seal as shown in FIGS. 3 and 4 is mounted on the plunger and additionally provides a deflector which, according to the teaching, promotes dispersion of the powder for enhancement of mixing.
Also noted is U.S. Pat. No. 4,410,321 as issued to Pearson et al. on Oct. 18, 1983. This storage system is a closed system with separate compartments. This device utilizes a needle to penetrate a stopper and through this needle is carried the concentrate. This system is for a mixed-drug delivery system using known intravenous administrative procedures. This system as exemplified in U.S. Pat. No. 4,410,321 is rather elaborate and is not adapted for use in other than intravenous applications and systems.
U.S. Pat. No. 4,462,224 was also noted. This patent issued to Dunshee et al. on July 31, 1984 and shows a flexible plastic bag with rupturable seams. When the seam is ruptured, then the contents of three compartments are mixed to provide instant hot or cold any may be reused. This device, although employing an envelope of flexible plastic, does not contain the potent drug portion in a glass retainer as does applicant's.
These prior art examples do not address the problem faced with the newly-available drugs, particularly cancer-treating drugs. Most of these drugs need to be mixed immediately or shortly before use. Many of the resulting mixed drugs are very toxic, even to the administrator of the drug, so that contact is very undesirable. Rubber gloves may be punctured or otherwise do not provide the needed protection. The invention to be described and as shown overcomes the objections to the prior art devices.